NCT00597090

Brief Summary

The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms. The goals of this study are:

  1. 1.Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
  2. 2.Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 20, 2011

Status Verified

January 1, 2011

Enrollment Period

7.9 years

First QC Date

January 8, 2008

Last Update Submit

January 19, 2011

Conditions

Infections

Keywords

Infectionslymphoma

Outcome Measures

Primary Outcomes (1)

  • Risk for developing infection or lymphoma due to allelic variation in genes of immune system that specialize in pathogen recognition compared to absence of allelic variation.

    6 years

Secondary Outcomes (1)

  • Risk for developing infectns due to somatic mutatns/polymorphisms in genes involved in signaling pathways downstream of receptors of immune recognitn.Characterize in vitro diff in functional responses to pathogens among genetic variants.

    6 years

Study Arms (1)

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population for this study is composed of patients with leukemia. It is projected that the marginal probability of an allelic variant in the TLR and an infection is 0.12 and 0.30 respectively in this patient population.

You may qualify if:

  • Subject must either:
  • Have histologically confirmed acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), follicular or mantle cell lymphoma RA-EB, RAEB-T newly diagnosed at first or second remission AND are going to receive or have received myelosuppressive chemotherapy; OR
  • Will receive or have received allogeneic HSCT for hematologic malignancy.
  • Subject has signed informed consent before entering the study.
  • Participation of children: For subjects under the age of 18, we will obtain the subject's and their parents' approval to enroll them.

You may not qualify if:

  • Subject has been diagnosed with leukemia other than acute myeloid leukemia RA-EB or RAEB-T or acute lymphocytic.
  • Subject is not going to receive chemotherapy or has not received chemotherapy.
  • Subject will undergo/had undergone HSCT for disease other than hematologic malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

We will genotype the genes of innate immune receptors to identify genetic polymorphisms associated with higher frequency of invasive infections or susceptibility to lymphoma. All specimens will be processed in the Infectious Diseases Laboratory at MSKCC. RNA will be extracted from peripheral blood mononuclear cells (PBMCs). Genotyping will be done from genomic DNA or from cDNA generated from RNA by RT-PCR. Cell lines will be created from PBMCs and will be analyzed in functional assays for responses to bacterial and fungal products (cytokine secretion, upregulation of cell surface molecules). All patient samples including genomic DNA, RNA, cDNA and cell lines will be banked in the Infectious Disease laboratory at MSKCC.

MeSH Terms

Conditions

InfectionsLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Genovefa Papanicolaou, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

February 1, 2003

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 20, 2011

Record last verified: 2011-01

Locations

US(1)